Connective Tissue DiseasesPAHNCT03446339
Pulmonary Hypertension Screening for Rheumatology Patients (SOPHIE)
An observational study of Connective Tissue Diseases and Systemic Sclerosis, run by The University of Hong Kong at 1 site in China.
Trial summary
Pulmonary arterial hypertension (PAH) is a serious and often fatal complication of connective tissue diseases including systemic sclerosis and systemic lupus erythematosus. It has been reported primarily from European series that the prevalence of PAH in patients with connective tissue diseases particularly systemic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Connective Tissue Diseases, Systemic Sclerosis, Systemic Lupus Erythematosus
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2017to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1,800 rheumatology patients with connective tissue diseases from public hospitals within Hospital Authority of Hong Kong
Who may be able to join
- Patientw with either (1) systemic lupus erythematosus, (2) systemic sclerosis, or (3) other connective tissue diseases at risk of pulmonary hypertension
- Voluntarily agrees to participate by providing written informed consent
- Age ≥ 18 at enrolment
Who cannot join
- Refuse to participate the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Territory-Wide Pulmonary Hypertension Screening Amongst Patients With Connective Tissue Diseases: A Prospective Screening Study
Pulmonary arterial hypertension (PAH) is a serious and often fatal complication of connective tissue diseases including systemic sclerosis and systemic lupus erythematosus. It has been reported primarily from European series that the prevalence of PAH in patients with connective tissue diseases particularly systemic sclerosis is as high as 15-20%. However, given the paucity of medical literature in the area from Chinese population, the prevalence of PAH amongst Chinese patients with these conditions is largely unknown. Even worse, PAH is often undiagnosed amongst patients with connective tissue diseases due to the lack of awareness and/or access to echocardiography, which is a non-invasive first-line screening tool for PAH. As a result, most patients at diagnosis of PAH are at a relatively late stage, rendering pharmacological treatment less effective. Here, the investigators propose a territory-wide pulmonary hypertension screening for patients with connective tissue disease in order to (1) detect pulmonary hypertension amongst patients with connective tissue disease through systematic screening, and (2) understand the prevalence of pulmonary hypertension in Chinese patients with connective tissue diseases.
Read the detailed description
Objectives:
- To detect pulmonary hypertension amongst patients with connective tissue diseases through systematic screening
- To understand the prevalence of pulmonary hypertension in Chinese patients with connective tissue diseases
Study design:
The study is a territory-wide pulmonary hypertension screening project. Patients fulfilling the inclusion and exclusion criteria will undergo screen echocardiography as baseline to detect subclinical pulmonary hypertension.
Screening procedure:
Participants will undergo usual clinical assessment by the rheumatology teams of the parent hospitals including standard 12-lead ECG and 6-minute hall walk distance. then they will be referred to the Division of Cardiology, the Department of Medicine, the University of Hong Kong for (1) Echocardiography and (2) BNP (or pro-NT BNP) assay. The echocardiography will be performed based on the European Society of Cardiology (ESC)/European Respiratory Society (ERS) Guidelines. The echocardiographic probability of pulmonary hypertension will be determined (low, intermediate, and high).
Statistical analysis and power calculation:
There are no studies on which to calculate a power equation, because there are no previous reports on the prevalence of pulmonary hypertension in Chinese rheumatological patients. The sample size is based on our local prevalence of the rheumatological diseases.
Continuous variables will be expressed in mean ± SD. Statistical comparisons were performed using Student's t test or Fisher's exact test, as appropriate. The outcomes would be analyzed.
- Medical subject headings
- Connective Tissue Diseases, Scleroderma, Systemic, Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of asymptomatic pulmonary hypertension in Chinese patients with connective tissue diseases
Proportion of patients diagnosed to have pulmonary hypertension
Measured: 36 months
Secondary outcomes (2)
Clinical predictor of Echocardiography for pulmonary hypertension in Chinese patients with connective tissue diseases
Cardiac functional and structural data for pulmonary hypertension detection
Measured: 36 months
Clinical predictor of BNP assay for pulmonary hypertension in Chinese patients with connective tissue diseases
Cardiac marker for cardiac problems indication
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start3 Aug 2017
- Primary completion31 Aug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chung-Wah David SIU, The University of Hong Kong
- Investigators
- David Chung-Wah Siu, Professor, Principal investigator, The Universtiy of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446339
- Sponsor's protocol ID
- PH_Screening_1.4.2017 ver.1
- Acronym
- PAH
- Status last verified
- Aug 2021
- First submitted
- 29 Jan 2018
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Territory-Wide Pulmonary Hypertension Screening Amongst Patients With Connective Tissue Diseases: A Prospective Screening Study
- ClinicalTrials.gov ID
- NCT03446339
- Acronym / sponsor ID
- PAH / PH_Screening_1.4.2017 ver.1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulmonary arterial hypertension (PAH) is a serious and often fatal complication of connective tissue diseases including systemic sclerosis and systemic lupus erythematosus. It has been reported primarily from European series that the prevalence of PAH in patients with connective tissue diseases particularly systemic sclerosis is as high as 15-20%. However, given the paucity of medical literature in the area from Chinese population, the prevalence of PAH amongst Chinese patients with these conditions is largely unknown. Even worse, PAH is often undiagnosed amongst patients with connective tissue diseases due to the lack of awareness and/or access to echocardiography, which is a non-invasive first-line screening tool for PAH. As a result, most patients at diagnosis of PAH are at a relatively late stage, rendering pharmacological treatment less effective. Here, the investigators propose a territory-wide pulmonary hypertension screening for patients with connective tissue disease in order to (1) detect pulmonary hypertension amongst patients with connective tissue disease through systematic screening, and (2) understand the prevalence of pulmonary hypertension in Chinese patients with connective tissue diseases.
Detailed description
Objectives:
- To detect pulmonary hypertension amongst patients with connective tissue diseases through systematic screening
- To understand the prevalence of pulmonary hypertension in Chinese patients with connective tissue diseases
Study design:
The study is a territory-wide pulmonary hypertension screening project. Patients fulfilling the inclusion and exclusion criteria will undergo screen echocardiography as baseline to detect subclinical pulmonary hypertension.
Screening procedure:
Participants will undergo usual clinical assessment by the rheumatology teams of the parent hospitals including standard 12-lead ECG and 6-minute hall walk distance. then they will be referred to the Division of Cardiology, the Department of Medicine, the University of Hong Kong for (1) Echocardiography and (2) BNP (or pro-NT BNP) assay. The echocardiography will be performed based on the European Society of Cardiology (ESC)/European Respiratory Society (ERS) Guidelines. The echocardiographic probability of pulmonary hypertension will be determined (low, intermediate, and high).
Statistical analysis and power calculation:
There are no studies on which to calculate a power equation, because there are no previous reports on the prevalence of pulmonary hypertension in Chinese rheumatological patients. The sample size is based on our local prevalence of the rheumatological diseases.
Continuous variables will be expressed in mean ± SD. Statistical comparisons were performed using Student's t test or Fisher's exact test, as appropriate. The outcomes would be analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1,800 rheumatology patients with connective tissue diseases from public hospitals within Hospital Authority of Hong Kong
Key inclusion criteria (3 listed)
- Patientw with either (1) systemic lupus erythematosus, (2) systemic sclerosis, or (3) other connective tissue diseases at risk of pulmonary hypertension
- Voluntarily agrees to participate by providing written informed consent
- Age ≥ 18 at enrolment
Key exclusion criteria (1 listed)
- Refuse to participate the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of asymptomatic pulmonary hypertension in Chinese patients with connective tissue diseases
Time frame: 36 months
Proportion of patients diagnosed to have pulmonary hypertension
2 secondary outcomes
Clinical predictor of Echocardiography for pulmonary hypertension in Chinese patients with connective tissue diseases
Time frame: 36 months
Clinical predictor of BNP assay for pulmonary hypertension in Chinese patients with connective tissue diseases
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Chung-Wah Siu, Professor principal investigator
The Universtiy of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Connective Tissue Diseases and Systemic Sclerosis, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Chung-Wah Siu, Professor (+852-22554694, cwdsiu@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of asymptomatic pulmonary hypertension in Chinese patients with connective tissue diseases (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.